Assessment of Left Ventricular Torsion by Echocardiography Study

Hypertrophic Cardiomyopathy Clinical Trial

— LVTorsion  

Official title:

Assessment of LV Torsion by Tissue Doppler Echocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589836
• Other study ID #: IRB 05-023
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: July 19, 2017
• Start date: June 2005
• Est. completion date: April 2008

Study information

• Verified date: July 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to learn about the twisting or wringing motion of the heartbeat called Left Ventricular Torsion (LV Torsion) which can be seen on ultrasound.

Description:

This study is designed to characterize the myocardial torsional behavior in patients with a variety of cardiac pathologies.

Simple and inexpensive methods for measurement of LV torsion could facilitate more widespread investigation of LV torsion, which might reveal significant relationships between torsional alterations and clinical outcomes and eventually lead to routine clinical application. Recently, Doppler tissue imaging (DTI) has been shown to accurately reflect myocardial velocity24,25 with better temporal resolution than MRI.26 Investigators hypothesize therefore that DTI might be used for quantification of LV rotation and torsion of the human heart. The purpose of the present study was to examine the accuracy of a novel method with DTI for quantifying the LV torsion in humans and tagged MRI as the reference standard.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male and female patients age 18 to 70 years

• Patients with hypertrophic cardiomyopathy

• Patients with the ability to exercise using a supine bicycle

• Ability to provide informed consent

Exclusion Criteria:

• Aortic valve stenosis classified as moderate to severe

• Severe left ventricular obstruction at rest (high gradients > 4m/second)

• Uncontrolled arrhythmias including atrial fibrillation, atrial flutter, frequent premature ventricular ectopic beats

• History of sustained ventricular tachyarrhythmia at any time

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Doppler Tissue Imaging	The purpose of the present study was to examine the accuracy of a novel method with DTI for quantifying the LV torsion in humans and tagged MRI as the reference standard.; LV torsion reflects the torsion (twisting deformation) occurring across the length of the ventricle (from the base to the apex) during the time interval defined by the beginning and end of contraction (or in physiologic terms, from end -diastole to end systole). In this study, end diastole was defined by the R wave of the ECG, while end systole is defined by minimum end-systolic volume or maximum of twisting deformation. The deformation is measured in degrees.; Once the measurements are performed by experimental method (i.e. TDI imaging) and reference method (i.e. MRI imaging) these two methods are then compared using Bland Altman analysis.; In a current study, mean difference between methods of torsion quantification was 0.57 degrees, while the standard deviation (SD) was 1.98 degrees.	1 1/2 hours